A risk-based maintenance approach for critical care medical devices: a case study application for a large hospital in a developing country

  • Stephen Vala
  • Peter Chemweno
  • Liliane Pintelon
  • Peter Muchiri
Case Studies


The availability of specialized medical equipment plays a critical role in the delivery of healthcare services. This becomes even more critical in developing countries where few medical devices are available in public hospitals, hence do not commensurate with demand, which leads to their overutilization. This often results in frequent failure of the medical devices and as a result, low availability. In turn, this leads to delayed treatment and consequently, access to affordable and quality healthcare by the disadvantaged in the society. This rather high unavailability of critical medical equipment in public hospitals in developing countries motivates this study, hence the necessitating the need to implement optimal maintenance strategies and operational protocols for maximizing equipment availability. However, selecting such optimal maintenance and operation strategies is not straightforward, and for this reason, a risk-based maintenance approach is proposed. The proposed approach addresses the aforementioned challenge through structured steps through which maintenance practitioners identify and prioritize prevalent failure modes. Based on the prioritized failure modes, operation and maintenance protocols may be derived. Moreover, the risk-based maintenance approach is useful for among other decisions, root cause analysis. The proposed risk-based maintenance approach consists of four steps; (1) data collection and standardization process, (2) modified failure mode and effect analysis step for prioritizing critical failure modes, (3) a root cause analysis step for analyzing the causes of recurrent failure modes, and (4) formulation of operation and maintenance strategies for mitigating equipment failure risks. The proposed approach is demonstrated in application in a case of large teaching and referral hospital in Kenya.


Risk-based maintenance Failure mode and effect analysis Maintenance and operational protocols Root cause analysis 


  1. Better equipped to care? Follow-up report on managing medical equipment. Accessed 8 Oct 2016
  2. Carmignani Gionata (2009) An integrated structural framework to cost based FMCEA: the priority-cost FMCEA. Reliab Eng Syst Saf 94:861–871CrossRefGoogle Scholar
  3. Fechter RJ, Barba JJ (2004) Failure mode effect analysis applied to the use of infusion pumps. In: Proceeding of the 26th annual international conference of the IEEE EMBS. San Francisco, CA, pp 3496–3499Google Scholar
  4. Fouad RH, Rawashdeh M, ALBashir A, AL-Sharif B (2012) Designing a computerized maintenance management system for medical devices in royal medical services.
  5. Jamshidi A, Rahimi SM, Ait-kadi D (2014) Medical devices inspection and maintenance; a literature review. In: Guan Y, Liao H (eds) Proceedings of the industrial and systems engineering research conferenceGoogle Scholar
  6. Khalaf A, Djouani K, Hamam Y, Alayli Y (2014) Maintenance strategies and failure—cost model for medical equipment. Qual Reliab Eng Int 31:935–947CrossRefGoogle Scholar
  7. Liu L, Ma S, Wang Z, Li P (2012) Use related risk analysis for medical devices based on improved FMEA. Work 41:5860–5865Google Scholar
  8. Liu HC, Liu L, Liu N (2013) Risk evaluation approaches in failure mode and effect analysis: A literature review. Expert Syst Appl 40:828–838CrossRefGoogle Scholar
  9. Lin Q, Wang D, Lin W, Liu H (2014) Human reliability assessment for medical devices based on failure mode and effects analysis and fuzzy linguistic theory. Saf Sci 62:248–256CrossRefGoogle Scholar
  10. Mahto D, Kumar A (2008) Application of root cause analysis in improvement of product quality and productivity. J Ind Eng Manag 1(2):16–53Google Scholar
  11. Mkalaf KA, Gibson P, Flanagan J (2013) A study of current maintenance strategies and the reliability of critical medical equipment in hospitals in relation to patient outcomes. Int J Soc Human Sci Eng 7(10):77–84Google Scholar
  12. Onofrio R, Piccagli F, Segato F (2015) Failure mode, effects and criticality (FMCEA) for medical devices: does standardization foster improvements in practice. Procedia Manufacturing 3:43–50CrossRefGoogle Scholar
  13. Performance Audit Report of the Auditor-General Specialized Healthcare Delivery at Kenyatta National Hospital Waiting-time for Cancer, Renal and Heart Patients. Office of the Auditor General November, 2012Google Scholar
  14. Pun KF, Ching KS, Chow MF, Chow HCW (2002) An effective-centered approach to maintenance management, A case study. J Qual Maint Eng 8(4):346–368CrossRefGoogle Scholar
  15. Rahimi SA, Jamshidi A, Ait-Kadi D, Ruiz A (2013) Using fuzzy cost based FMEA, GRA and profitability theory for minimizing failures at a healthcare diagnosis service. Qual Reliab Eng Int 31(4):601–615CrossRefGoogle Scholar
  16. Rahimi SA, Jamshidi A, Ait-Kadi D, Ruiz A, Rebaiaia ML (2016) Prioritization of failures in radiation therapy delivery. IFAC -PapersOnline 49–12:1898–1903CrossRefGoogle Scholar
  17. Ridgway RM (2009a) Optimizing our PM program. J Biomed Instrum Technol 43:244–254CrossRefGoogle Scholar
  18. Ridgway MG (2009b) Manufacturer-recommended pm intervals: is it time for a change? Biomed Instrum Technol 43(6):498–500CrossRefGoogle Scholar
  19. Rosen MA, Lee BH, Sampson JB, Koka R, Chima AM, Ogbuagu OU, Marx MK, Kamara TB, Koroma M, Jackson EV Jr (2014) Failure mode and effects analysis applied to the maintenance and repair of anesthetic equipment in an austere medical environment. Int J Qual Healthcare 26(4):404–410CrossRefGoogle Scholar
  20. Sutrisno A, Lee T (2011) Service reliability assessment using failure mode and effect analysis (FMEA): survey and opportunity roadmap. Int J Eng Sci Technol 3(7):25–38Google Scholar
  21. Taghipour S, Banjevic D, Jardine AKS (2011) Reliability analysis of maintenance data for complex medical devices. Qual Reliab Eng Int 27:71–84CrossRefGoogle Scholar
  22. United States Environmental Protection Agency Guidance for Preparing Standard Operating Procedures (SOPs) EPA QA/G–‐6 [EPA/600/B–‐07/001 2007Google Scholar
  23. Von Ahsen A (2008) Cost-oriented failure mode and effects analysis. Int J Qual Reliab Manag 25:466–479CrossRefGoogle Scholar
  24. Xiuxu Z, Xiaoli B (2010) The application of FMEA method in risk management of medical device during the lifecycleGoogle Scholar

Copyright information

© The Society for Reliability Engineering, Quality and Operations Management (SREQOM), India and The Division of Operation and Maintenance, Lulea University of Technology, Sweden 2018

Authors and Affiliations

  • Stephen Vala
    • 1
  • Peter Chemweno
    • 2
  • Liliane Pintelon
    • 3
  • Peter Muchiri
    • 1
  1. 1.School of EngineeringDedan Kimathi University of TechnologyNyeriKenya
  2. 2.School of EngineeringMoi UniversityEldoretKenya
  3. 3.Centre for Industrial ManagementKU LeuvenHerveleeBelgium

Personalised recommendations